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On 4 March 2014, the European Commission (EC) published Regulation (EU) No 202/2014 in the Official Journal of the European Union (OJ EU) to amend Annex I of the “Plastics Regulation” (EU) No 10/2011.
Based on the opinions issued by the European Food Safety Authority (EFSA) in July 2012, the following two substances were concluded to pose no safety concerns for the consumers:
Also, the hydrolysis product of FCM substance No 988 is 1,3- benzenedimethanamine (which is FCM substance 421) and it should be controlled. A group restriction has therefore been introduced for FCM substance numbers 421 and 988 in Table 2 of Annex I.
FCM substance No 340, dicyanodiamide, which is an approved FCM substance already listed in Table 1 of Annex 1, now has a specific migration limit (SML) of 60 mg/kg.
A statement on the verification of compliance with primary aromatic amines (PAA) has been introduced in Table 3 of Annex I.
Table A below summaries all these changes.
Table A. Summary of changes to Annex I of The Plastics Regulation (EU) No 10/2011
The following two FCM substances are added:
Dicyanodiamide (No. 340), which is currently an authorised additive for use in plastics, has been given an SML of 60 mg/kg.
|Table 2||A group restriction has been introduced for 1,3-benzenedimethanamine (No. 421) and 1,3-bis(isocyanatomethyl)benzene (No. 988), with an SML of 0.05 mg/kg.|
Verification of compliance with PAA with restrictions set in Annex II (2) is necessary when the substance contains aniline as an impurity.
These amendments have entered into force on 24 March 2014.